Indian drugmakers to bring cheap HCV drug Sovaldi to developing world

By Dan Stanton contact

- Last updated on GMT

Gilead grants Sovaldi license to Indian generic firms
Gilead has granted seven Indian drugmakers licenses to produce generic versions of its $1,000 a pill drug Sovaldi to increase access to hepatitis C medicines in 91 developing countries.

Last December, Gilead’s Sovaldi (sofosbuvir) became the first approved drug to treat chronic hepatitis C virus (HCV) infection without the need for co-administration of interferon. However, the minimum treatment time is 12 weeks and costs $84,000 (€65,000) in the US​ – equating to around $1,000 per pill.

This has led to some criticism of Gilead, especially in developing countries – the US-based group Initiative for Medicines, Access, & Knowledge (I-MAK),​ for example, tried to block Gilead’s patent in India – but the firm announced yesterday it has signed non-exclusive licensing agreements with seven India-based generic drugmakers to expand access to the drug in 91 developing countries.

“These generic licensing agreements are part of our commitment to increase access to hepatitis C medicines in the developing world,”​ Gilead spokesperson Arran Attridge told in-Pharmatechnologist.com.

She added this was one of a number of strategies Gilead was pursuing as part of its commitment to increase access to hepatitis C, along with “direct pricing negotiation with local governments, tiered pricing, and partnerships with non-governmental organizations.”

The seven generic firms granted the licenses are: Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific, and Strides Arcolab.  According to Gilead, all the companies will receive a complete technology transfer of Sovaldi’s manufacturing process to enable them to scale up production as quickly as possible, and the firms can set their own price.

None of the generic firms responded to requests for more information from this publication but between them up Gilead has suggested 100 million people living with hepatitis C will be granted cheap access to Sovaldi in the countries highlighted in green below.

Sovaldi generic
91 countries will be supplied cheaper generic versions of Gilead's Sovaldi

Gilead will be entitled to royalties from the sale of these generics but we asked Attridge how the firm could ensure these cheaper generics do not dilute its own market share in the developed world.

“The agreements are legally binding contracts that permit the sale of product manufactured only in the agreed countries,”​ we were told.

“The licensees also commit to working with Gilead on plans to minimize diversion of product outside those countries, and must inform us of their intentions to launch in a country at least six months in advance of doing so.”

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